Dry Eye DiseasePhase 4NCT01014078
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
A Phase 4 study testing Azithromycin Ophthalmic Solution, 1% in people with Dry Eye Disease, run by Merck Sharp & Dohme LLC at 9 sites in United States.
Trial summary
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Azithromycin Ophthalmic Solution, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a current diagnosis of dry eye in one or both eyes
- Moderate to severe degree of meibomian gland plugging
- Have best corrected visual acuity in both eyes of at least +0.7 LogMAR
- If female, are non-pregnant or non-lactating
Who cannot join
- Have anterior blepharitis
- Have lid structural abnormalities
- Have suspected ocular fungal or viral infection
- Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study
- Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.
- Unable to withhold the use of contact lenses during the study
Show all 14Show fewer
- Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication.
- Have a history of post vitreous detachment.
- Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).
- Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.
- Have a congenitally absent meibomian gland or lacrimal gland.
- Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
- Have a serious medical condition which would confound study assessments.
- Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Sall Research Medical Center, Inc.
Artesia, California, 90701
Abrams Eye Center
Cleveland, Ohio, 44115
OSU - College of Optometry
Columbus, Ohio, 43210
Tauber Eye Center
Kansas City, Missouri, 64111
Kentucky Lions Eye Center
Louisville, Kentucky, 40207
David Wirta, MD, Inc.
Newport Beach, California, 92663
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Eye Clinics of South Texas
San Antonio, Texas, 78209
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.
- Conditions
- Dry Eye Disease
- Being tested
- Azithromycin Ophthalmic Solution, 1%, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Ophthalmic Solution, 1%Drug
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
PlaceboDrug
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin Ophthalmic Solution, 1% | Experimental | Not described Receives: Drug: Azithromycin Ophthalmic Solution, 1% |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break-Up Time (TBUT)
Measured: 4 weeks
Secondary outcomes (4)
Corneal Staining
Measured: 4 weeks
Tear Volume
Measured: 4 weeks
Meibomian gland plugging
Measured: 4 weeks
Subject-rated scores of dry eye symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Reza Haque, MD, PhD, Study chair, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014078
- Sponsor's protocol ID
- 041-116
- Other IDs
- P08646
- Status last verified
- Sep 2011
- First submitted
- 12 Nov 2009
- Last updated
- 26 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01014078
- Acronym / sponsor ID
- 041-116
- Conditions
- Dry Eye Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Ophthalmic Solution, 1% | Experimental | Drug: Azithromycin Ophthalmic Solution, 1% |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a current diagnosis of dry eye in one or both eyes
- Moderate to severe degree of meibomian gland plugging
- Have best corrected visual acuity in both eyes of at least +0.7 LogMAR
- If female, are non-pregnant or non-lactating
Key exclusion criteria (14 listed)
- Have anterior blepharitis
- Have lid structural abnormalities
- Have suspected ocular fungal or viral infection
- Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study
- Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin Ophthalmic Solution, 1%1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days) | Drug | Azithromycin Ophthalmic Solution, 1% |
| Placebo1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days) | Drug | Placebo |
Primary outcome
Tear Break-Up Time (TBUT)
Time frame: 4 weeks
4 secondary outcomes
Corneal Staining
Time frame: 4 weeks
Tear Volume
Time frame: 4 weeks
Meibomian gland plugging
Time frame: 4 weeks
Subject-rated scores of dry eye symptoms
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Haque, MD, PhD study chair
Medical Monitor
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin Ophthalmic Solution, 1% in people with Dry Eye Disease, run by Merck Sharp & Dohme LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Break-Up Time (TBUT) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.